Class II

Medical Device Recall: SIGNA Architect, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC · October 28, 2024

Reason for Recall

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

Distribution

Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.

States Affected

NATIONWIDE

Quantity Affected

53 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0518-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.